The following data is part of a premarket notification filed by Rebound Therapeutics with the FDA for Aurora Surgiscope System.
| Device ID | K191861 |
| 510k Number | K191861 |
| Device Name: | Aurora Surgiscope System |
| Classification | Endoscope, Neurological |
| Applicant | Rebound Therapeutics 13900 Alton Parkway Suite 120 Irvine, CA 92618 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong Rebound Therapeutics 13900 Alton Parkway Suite 120 Irvine, CA 92618 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-11 |
| Decision Date | 2019-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860624000462 | K191861 | 000 |
| 00860624000455 | K191861 | 000 |
| 00850002332131 | K191861 | 000 |
| 00860624000400 | K191861 | 000 |